VASCEPA® (pronounced vas-EE-puh)
(icosapent ethyl) capsules
What is VASCEPA?
VASCEPA is a prescription medicine used along with certain
medicines (statins) to reduce the risk of heart attack, stroke, and
certain types of heart issues requiring hospitalization in adults
with heart (cardiovascular) disease, or diabetes and 2 or more
additional risk factors for heart disease. It’s also used along
with a low-fat and low-cholesterol diet to lower high levels of
triglycerides (fats) in adults.
It is not known if VASCEPA changes your risk of having
inflammation of your pancreas (pancreatitis).
It is not known if VASCEPA is safe and effective in children.
Do not take VASCEPA if you are allergic to icosapent ethyl or
any of the ingredients in VASCEPA. See the end of this summary
for a complete list of ingredients in VASCEPA.
Before taking VASCEPA, tell your doctor about all of your
medical conditions, including if you:
• have diabetes.
• have a low thyroid problem (hypothyroidism).
• have a liver problem.
• have a pancreas problem.
• are allergic to fish or shellfish. It is not known if people who
are allergic to fish or shellfish are also allergic to VASCEPA.
• are pregnant, or planning to become pregnant. It is not known
if VASCEPA will harm your unborn baby.
• are breastfeeding or plan to breastfeed. VASCEPA can pass
into your breast milk, and may harm your baby. Talk to your
doctor about the best way to feed your baby if you take
Tell your doctor about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and
dietary or herbal supplements.
VASCEPA can interact with certain other medicines that you are
Especially tell your doctor if you take medicines that affect your
blood clotting (anticoagulants or blood thinners).
How should I take VASCEPA?
• Take VASCEPA exactly as your doctor tells you to take it.
• Do not change your dose or stop taking VASCEPA without
talking to your doctor.
• Do not take more capsules than what is prescribed by your
- If you are prescribed the 0.5 gram capsules, you should not
take more than 8 capsules each day with food.
- If you are prescribed the 1 gram capsules, you should not
take more than 4 capsules each day with food.
• Take VASCEPA capsules whole. Do not break, crush, dissolve, or
chew VASCEPA capsules before swallowing.
• If you miss a dose of VASCEPA, take it as soon as you
remember. However, if you miss one day of VASCEPA, do not
double your dose when you take it.
• Your doctor may start you on a diet that is low in saturated
fat, cholesterol, carbohydrates, and low in added sugars before
giving you VASCEPA. Stay on this diet while taking VASCEPA.
• Your doctor may do blood tests to check your triglyceride and
other lipid levels while you take VASCEPA.
What are the possible side effects of VASCEPA?
VASCEPA may cause serious side effects, including:
• Heart rhythm problems (atrial fibrillation and atrial
flutter). Heart rhythm problems which can be serious and
cause hospitalization have happened in people who take
VASCEPA, especially in people who have heart (cardiovascular)
disease or diabetes with a risk factor for heart (cardiovascular)
disease, or who have had heart rhythm problems in the past.
Tell your doctor if you get any symptoms of heart rhythm
problems such as feeling as if your heart is beating fast and
irregular, lightheadedness, dizziness, shortness of breath,
chest discomfort, or you faint.
• Possible allergic reactions if you are allergic to fish or
shellfish. Stop taking VASCEPA and tell your doctor right
away or get emergency medical help if you have any signs or
symptoms of an allergic reaction.
• Bleeding. Serious bleeding can happen in people who take
VASCEPA. Your risk of bleeding may increase if you are also
taking a blood thinner medicine.
If you have liver problems and are taking VASCEPA, your doctor
should do blood tests during treatment.
The most common side effects of VASCEPA include: muscle and
joint pain; swelling of the hands, legs, or feet; constipation; gout;
and heart rhythm problems (atrial fibrillation).
These are not all the possible side effects of VASCEPA. Call your
doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
How should I store VASCEPA?
• Store VASCEPA at room temperature between 68° to 77° F
(20° to 25° C).
• Safely throw away medicine that is out of date or no longer
Keep VASCEPA and all medicine out of the reach of children.
General information about the safe and effective use of
VASCEPA. Medicines are sometimes prescribed for purposes
other than those listed in a Patient Information leaflet. Do not
use VASCEPA for a condition for which it was not prescribed. Do
not give VASCEPA to other people, even if they have the same
symptoms that you have. It may harm them. You can ask your
pharmacist or healthcare provider for information about VASCEPA
that is written for health professionals.
What are the ingredients in VASCEPA?
Active ingredient: icosapent ethyl
Inactive ingredients: tocopherol, gelatin, glycerin, maltitol,
sorbitol, and purified water
VASCEPA is a registered trademark of the Amarin group of companies.
©2019 Amarin Pharma, Inc. Bridgewater NJ, 08807. All rights reserved.
PP00120M Revised: 12/2019
Distributed by: Amarin Pharma, Inc. Bridgewater, NJ, USA
Manufactured for: Amarin Pharmaceuticals Ireland Limited Dublin, Ireland
+1-855-VASCEPA (+1-855-827-2372) www.vascepa.com
For more information, go to www.vascepa.com or call 1-855-VASCEPA
This Patient Information has been approved by the U.S. Food and Drug